Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm

Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is
the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent
Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A
decision on funding the full study should be forthcoming in the early part of 2015. The
primary aim of the study is to compare the proportion of advanced cancer patients who have a
hospitalization or emergency department visit in the last 6 months of life before and after
implementation of a new care model that provides more comprehensive symptom management and
supportive care, including earlier referral to palliative care. The secondary comparative
aim is to assess measures of quality of life and satisfaction in both groups. To accomplish
the aims of the study by the end of the funding period, we propose to begin data collection
in advance of a funding decision. Should the study not receive funding, the data collected
will be used to inform decisions regarding other funding applications and/or implementation
of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not
represent more than minimal risk for the patients enrolled.

This protocol is for the first phase of the study, which is the enrollment and collection of
data on the control group, to serve as the baseline for comparison regarding
hospitalizations, ED visits, quality of life, and patient and family satisfaction. To
achieve sufficient number of subjects and observed deaths in the control group, we are
targeting the start of enrollment and data collection in this group during the third quarter
of 2014. If the project is funded, the intervention and enrollment in the intervention group
are targeted to start in the second quarter of 2016. Background and study aims are presented
for the entire project to provide context, but the intent of this application is only for
approval of the enrollment and data collection on the control subjects (which contributes to
aims 2 and 3 of the larger project). A second protocol would be presented for review and
approval at the start of the intervention if the project funding is granted.

In phase one of the project, subjects would be approached and consented at the point of a
determination/diagnosis of advanced cancer and followed until the end of life or the start
of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.

This current study is to collect data on the control group only. After system redesign, we
will open an intervention arm study to collect data after implementation of the new care
model (about 18-24 months from start of control phase).

Inclusion Criteria:

- Newly diagnosed with a solid tumor-type cancer that is considered either advanced and
unresectable or metastatic

Exclusion Criteria:

- Non-English speaking

- Age < 18